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This Month’s Focus: Quality, Validation & Regulatory Compliance

Using fundamental powder properties to optimize flowability

Many methods of measuring powder flowability aren’t predictive and can’t be used to select or design the optimal hopper or bin. Shear cells offer a better approach. This article details how to use them to quantify flow behavior and to design vessels that ensure reliable flow.

Using low-content active ingredients as an indicator of overall blend and tablet uniformities

This article describes the results of blending uniformity studies of a tablet formulation comprising 18 active ingredients, some of which are present in very small amounts. Testing to determine whether all the ingredients are present in the stated amounts would be time consuming and expensive. However, if the low-content active ingredients are uniform in the final blend and in the tablets, then it may be reasonable to assume that the other actives are uniform, too.

A look into the world of cannabinoid formulation

The cannabis industry exists in a Wild West environment, where state law-abiding scientists and fringe characters operate under a variety of conflicting regulations. This article describes that world and provides advice to formulators on the science of developing medicinal cannabinoid products.

Back Page: What does a validation expert do and why do I need one?

Although it’s a regulatory requirement, the FDA only outlines how to perform validation.

General Features

Spotlight on Nutraceuticals: Ten questions to ask a contract manufacturer—and yourself—about liquid-filled capsules

Liquid-filled capsules continue to attract dietary supplement consumers and product developers. More often than not, nutraceutical product developers outsource the manufacture of these dosage forms. This article discusses several factors you and your contract manufacturer should consider when developing dietary supplements as liquid-filled capsules.

The evolution of on-dose product identification

On-dose identification enhances patient safety and differentiates your product. This article reviews traditional methods of adding identifiers to tablets and capsules and discusses new technologies that will increase safety, protect the supply chain, and meet manufacturers’ business needs.

Eye on Excipients: On-dose product identification

This edition of the column discusses how porous silica provides on-dose product identification and improves patient compliance with targeted, sustained drug release.

November Content

Annual Buyer’s & Reference Guide

Issue Focuses

January: Capsule Filling

March: Outsourcing

April: Coating

May: Packaging

June: Solid Dosage Sourcebook

July: Excipients & Formulation

September: Tabletting

October: Quality, Validation & Regulatory Compliance

November: Annual Buyer’s Guide

Contact the editor:
Matthew Knopp
1155 Northland Drive
St. Paul, MN 55120
Fax 651-287-5650

Thank You!

T&C relies on professionals like you to keep our readers informed about the latest technology, methods, and equipment. Thank you for considering T&C for placement of your article.

Special Sections
Capsule Filling
Granulation & Drying
Outsourcing: Formulation, Manufacturing, Packaging, Research & Lab Services
1. Counters/Bottle Fillers
2. Dedusters
1. Test & Inspection Equipment
2. Multi-layer Tabletting
1. Particle Size: Reduction, Separation, & Analysis
2. Powder Transfer & Containment
Solid Dosage Sourcebook
Excipients & Formulation
1. Tooling
2. Mixers & Blenders
Liquid Capsule Filling
Quality, Validation, & Regulatory Compliance
1. Blister Packaging
2. Tablet & Capsule Identification
Annual Buyer’s Guide
*Issue includes “Spotlight on Nutraceuticals” insert.

Buyers Guide
Tables and Capsules Source Book